A Study of LY3532226 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3532226 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923269
• Other study ID #: 17834
• Secondary ID: J2V-MC-GZLA
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2021
• Est. completion date: October 28, 2021

Study information

• Verified date: December 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Overtly healthy males or females not of childbearing potential.
• Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

• Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data
• Have a history of malignancy within 5 years prior to screening
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
• Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X the upper limit of normal (ULN) or total bilirubin level (TBL) >1.5X ULN
• Have serum triglyceride level =5 mmol/L (442.5 mg/dL)
• Have undergone any form of bariatric surgery
• Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3532226
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Week 8
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226	PK: Cmax of LY3532226	Day 1 through Day 43
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226	PK: AUC of LY3532226	Day 1 through Day 43
Secondary	PK: Time to Maximum Concentration (Tmax) of LY3532226	PK: Tmax of LY3532226	Day 1 through Day 43